- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05523843
Pilot Study on the Clinical Utility of the Tulsa Life Chart
Pilot Study on the Clinical Utility of the Tulsa Life Chart: A Graphical Representation of Patient Life History
Study Overview
Status
Intervention / Treatment
Detailed Description
Understanding the longitudinal course of mental health is critical for case conceptualization. One approach for capturing the complexity of an individual's illness course is to depict it graphically. The first attempt for this method was the National Institute of Mental Health Life Chart for Bipolar Disorder. Subsequent research indicated Life Charts are useful clinically and time- and cost-effective. Despite clinical utility and time and cost efficiency, this approach has not been widely adopted in the mental health field. Possible explanations are the prior focus on bipolar disorder, time required to collect information, and prior versions have not had automatic translation of the patient information into an image.
The Tulsa Life Chart (TLC) was developed by researchers at the Laureate Institute for Brain Research (LIBR). The TLC was developed to address weaknesses of previous life chart methods and help patients and healthcare professionals (HCPs) quickly identify patterns of mental health symptoms across diagnostic categories. To date only one formal exploration of the TLC has been conducted in a sample of individuals with mood, anxiety, eating disorders, and substance use disorders, which suggested that participants felt the TLC was helpful in understanding their mental health symptoms and was pleasant to complete. Unpublished focus groups with HCPs suggest HCPs believe the TLC could help to improve patient encounters by increasing understanding of patients and facilitating conversations. Based on these findings the goal of the proposed study is to examine clinical usability, utility, and feasibility in a pragmatic pilot trial.
The current trial will recruit individuals seeking treatment within the Laureate Psychiatric Clinic and Hospital and healthcare professionals involved with their care. Treatment-seeking patients who are invited to participate will be asked to complete the TLC soon after establishing care in a health system setting. Subsequently, the patient's HCP will review the chart during the intake process and complete several measures related to the chart and their experience (baseline assessment point). Patients and HCPs will engage in treatment as usual in between the TLC and assessment time points. Prior to or shortly following discharge/termination of treatment (approximately 4 to 12 weeks depending on the clinic), patients and HCPs will be asked to again complete questions to determine the TLC's usefulness during treatment. The overarching aim of the current study is to examine the usefulness of the Tulsa Life Chart for treatment-seeking individuals and healthcare professionals.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oklahoma
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Tulsa, Oklahoma, United States, 74008
- Laureate Institute for Brain Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Treatment Seekers Inclusion Criteria:
- Actively seeking mental health treatment at Laureate Psychiatric Clinic and Hospital
- Provision of informed consent or if <18 assent and parental consent
- Age 15 to 65 years
- Necessary resources to engage in a technology-based intervention
- English proficiency
- Willingness to grant access to medical records
HCPs Inclusion Criteria:
- Employed at Laureate Psychiatric Clinic and Hospital in a patient care role
- Informed consent
- English proficiency
- Access to resources to engage in technology-based intervention
Exclusion Criteria:
Treatment Seekers Exclusion Criteria:
- Active suicidal ideation with plan or intent
- No access to resources to participate in a technology-based intervention
- Completed more than 2 sessions of therapy with their current provider prior to enrollment in the study
- Not proficient in English
HCPs Exclusion Criteria:
- No access to resources to participate in a technology-based intervention
- Not proficient in English
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Treatment seeking individuals
Individuals seeking treatment in the Laureate Psychiatric Clinic and Hospital (LPCH).
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The TLC is a self-administered, interactive assessment of patient history.
Participants are asked to provide information from birth to their current age in developmental epochs (i.e., ages 0 to 5; 6 to 10; 11 to 14; 15 to 18; 19 to 25; 26 to 35; and so on in 10-year increments).
Participants are first asked to rate their average mood during the epoch.
They are then asked about locations lived, schools attended, people they were close to, hobbies, medical conditions, medications, hospitalizations, direct and indirect substance use exposure, mental health symptoms, mental health treatment, and important life events.
The information is then displayed in an interactive, graphic of the individual's life that is reviewable by the patient and the healthcare providers enrolled in the study that the patient consents to having access.
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Healthcare professionals
Healthcare professionals (HCPS) include nurses, psychologists, therapists, medical doctors, dieticians, etc who work at LPCH and are engaged in direct patient care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Patient)
Time Frame: Baseline assessment
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Validated self-report survey in which participants indicate how usable the assessment tool was, with scores ranging from 18 to 126.
Higher scores indicate greater usability.
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Baseline assessment
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mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Healthcare Professional)
Time Frame: Baseline assessment
|
Validated self-report survey in which healthcare professional participants indicate how usable the assessment tool was, with scores ranging from 18 to 126.
Higher scores indicate greater usability.
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Baseline assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Patient)
Time Frame: Baseline assessment
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Subscale of a validated self-report survey in which patient participants report how easy the assessment tool was to use.
Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use.
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Baseline assessment
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mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Healthcare Professional)
Time Frame: Baseline assessment
|
Subscale of a validated self-report survey in which healthcare professional participants report how easy the assessment tool was to use.
Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use.
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Baseline assessment
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mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Patient)
Time Frame: Baseline assessment
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Subscale of a validated self-report survey in which patients rate their satisfaction with the assessment tool and the interface of the tool.
Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
|
Baseline assessment
|
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mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Healthcare Professional)
Time Frame: Baseline assessment
|
Subscale of a validated self-report survey in which healthcare professionals rate their satisfaction with the assessment tool and the interface of the tool.
Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
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Baseline assessment
|
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mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Patient)
Time Frame: Baseline assessment
|
Subscale of a validated self-report survey in which patients rate the usefulness of the assessment tool.
Usefulness scores range from 6 to 42 with higher scores indicating greater usefulness.
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Baseline assessment
|
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mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Healthcare Professional)
Time Frame: Baseline assessment
|
Subscale of a validated self-report survey in which healthcare professionals rate the usefulness of the assessment tool.
Usefulness scores range from 6 to 42 with higher scores indicating greater usefulness.
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Baseline assessment
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Time spent to complete the Tulsa Life Chart (Patient)
Time Frame: Baseline assessment
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Treatment seekers self-report of time to complete the TLC and embedded time count from the TLC application.
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Baseline assessment
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Time spent to reviewing the Tulsa Life Chart (Healthcare Professional)
Time Frame: Baseline assessment
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Healthcare professionals' self-report of time spent reviewing the TLC and embedded time count from the TLC application.
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Baseline assessment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Patient)
Time Frame: Assessment two - on average 4 to 12 weeks after baseline assessment
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Validated self-report survey in which participants indicate how usable the assessment tool was, with scores ranging from 18 to 126.
Higher scores indicate greater usability.
|
Assessment two - on average 4 to 12 weeks after baseline assessment
|
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Change in perception of usefulness
Time Frame: Change from baseline to the post-treatment timepoint, approximately 4 - 12 weeks after baseline
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Change in mHealth App Usability Questionnaire (MAUQ) score from first assessment time point to second assessment time point.
Scores on the MAUQ range from 18 to 126.
Higher scores indicate greater usability.
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Change from baseline to the post-treatment timepoint, approximately 4 - 12 weeks after baseline
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mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Patient)
Time Frame: Assessment two - on average 4 to 12 weeks after baseline assessment
|
Subscale of a validated self-report survey in which patient participants report how easy the assessment tool was to use.
Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use.
|
Assessment two - on average 4 to 12 weeks after baseline assessment
|
|
mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Healthcare Professional)
Time Frame: Assessment two - on average 4 to 12 weeks after baseline assessment
|
Subscale of a validated self-report survey in which healthcare professional participants report how easy the assessment tool was to use.
Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use.
|
Assessment two - on average 4 to 12 weeks after baseline assessment
|
|
mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Patient)
Time Frame: Assessment two - on average 4 to 12 weeks after baseline assessment
|
Subscale of a validated self-report survey in which patients rate their satisfaction with the assessment tool and the interface of the tool.
Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
|
Assessment two - on average 4 to 12 weeks after baseline assessment
|
|
mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Healthcare Professional)
Time Frame: Assessment two - on average 4 to 12 weeks after baseline assessment
|
Subscale of a validated self-report survey in which healthcare professionals rate their satisfaction with the assessment tool and the interface of the tool.
Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
|
Assessment two - on average 4 to 12 weeks after baseline assessment
|
|
mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Patient)
Time Frame: Assessment two - on average 4 to 12 weeks after baseline assessment
|
Subscale of a validated self-report survey in which patients rate the usefulness of the assessment tool.
Usefulness scores range from 6 to 42 with higher scores indicating greater usefulness.
|
Assessment two - on average 4 to 12 weeks after baseline assessment
|
|
mHealth App mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Healthcare Professional)
Time Frame: Assessment two - on average 4 to 12 weeks after baseline assessment
|
Subscale of a validated self-report survey in which healthcare professionals rate the usefulness of the assessment tool.
Usefulness scores range from 6 to 42 with higher scores indicating greater usefulness.
|
Assessment two - on average 4 to 12 weeks after baseline assessment
|
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Utility Questionnaire (Patient)
Time Frame: Baseline assessment
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This measure was created for the purpose of the current study to measure how useful the assessment tool was in multiple domains.
This measure asks treatment seekers questions pertaining to their experience using the Tulsa Life Chart including: ease of understanding and impact of completing the Tulsa Life Chart on remembering life events, understanding of mental health patterns, communication with their provider, and motivation for treatment engagement.
Scores range from 6 to 28 with higher scores indicating greater utility for patients.
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Baseline assessment
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Utility Questionnaire (Healthcare Professional)
Time Frame: Baseline assessment
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This measure was created for the purpose of the current study to measure how useful the assessment tool was in multiple domains.
This measure asks healthcare professionals questions pertaining to their experience viewing their patient's Tulsa Life Chart.
Domains include ease of understanding the chart; usefulness in diagnosing their patient; and impact on understanding patient's psychosocial history, understanding patterns in their patient's mental health, and facilitating conversations.
Scores range from 7 to 35 with higher scores indicating greater utility for healthcare professionals.
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Baseline assessment
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Utility Questionnaire (Patient)
Time Frame: Assessment two - on average 4 to 12 weeks after baseline assessment
|
This measure was created for the purpose of the current study to measure how useful the assessment tool was in multiple domains.
This measure asks treatment seekers questions pertaining to their experience using the Tulsa Life Chart including: ease of understanding and impact of completing the Tulsa Life Chart on remembering life events, understanding of mental health patterns, communication with their provider, and motivation for treatment engagement.
Scores range from 5 to 23 with higher scores indicating greater utility for patients.
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Assessment two - on average 4 to 12 weeks after baseline assessment
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Utility Questionnaire (Healthcare Professional)
Time Frame: Assessment two - on average 4 to 12 weeks after baseline assessment
|
This measure was created for the purpose of the current study to measure how useful the assessment tool was in multiple domains.
This measure asks healthcare professionals questions pertaining to their experience viewing their patient's Tulsa Life Chart.
Domains include impact on therapy; ease of understanding the chart; usefulness in diagnosing their patient; and impact on understanding patient's psychosocial history, understanding patterns in their patient's mental health, and facilitating conversations.
Scores range from 8 to 35 with higher scores indicating greater utility for healthcare professionals.
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Assessment two - on average 4 to 12 weeks after baseline assessment
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Likelihood of recommending the Tulsa Life Chart to other patients (Patient)
Time Frame: Baseline assessment
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One question will be used to assess the patient's likelihood of recommending the Tulsa Life Chart.
"How likely are you to recommend the Tulsa Life Chart to someone else who may be experiencing mental health symptoms?"
Scores range from 1 to 5, with higher scores indicating greater likelihood of recommending to the chart.
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Baseline assessment
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Likelihood of recommending the Tulsa Life Chart to other healthcare professionals (Healthcare Professional)
Time Frame: Baseline assessment
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One question will be used to assess the patient's likelihood of recommending the Tulsa Life Chart to other healthcare professionals.
"Based on this experience, how likely are you to recommend the Tulsa Life Chart to other providers?"
Scores range from 1 to 5, with higher scores indicating greater likelihood of recommending to the chart.
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Baseline assessment
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Likelihood of recommending the Tulsa Life Chart to other patients (Patient)
Time Frame: Assessment two - on average 4 to 12 weeks after baseline assessment
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One question will be used to assess the patient's likelihood of recommending the Tulsa Life Chart.
"How likely are you to recommend the Tulsa Life Chart to someone else who may be experiencing mental health symptoms?"
Scores range from 1 to 5, with higher scores indicating greater likelihood of recommending to the chart.
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Assessment two - on average 4 to 12 weeks after baseline assessment
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Likelihood of recommending (Healthcare Professional)
Time Frame: Assessment two - on average 4 to 12 weeks after baseline assessment
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One question will be used to assess the patient's likelihood of recommending the Tulsa Life Chart to other healthcare professionals.
"Based on this experience, how likely are you to recommend the Tulsa Life Chart to other providers?"
Scores range from 1 to 5, with higher scores indicating greater likelihood of recommending to the chart.
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Assessment two - on average 4 to 12 weeks after baseline assessment
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Collaborators and Investigators
Investigators
- Principal Investigator: Robin Aupperle, PhD, Laureate Institute for Brain Research
Publications and helpful links
General Publications
- Aupperle RL, Paulus MP, Kuplicki R, Touthang J, Victor T, Yeh HW; Tulsa 1000 Investigators; Khalsa SS. Web-Based Graphic Representation of the Life Course of Mental Health: Cross-Sectional Study Across the Spectrum of Mood, Anxiety, Eating, and Substance Use Disorders. JMIR Ment Health. 2020 Jan 28;7(1):e16919. doi: 10.2196/16919.
- Manderscheid RW, Ryff CD, Freeman EJ, McKnight-Eily LR, Dhingra S, Strine TW. Evolving definitions of mental illness and wellness. Prev Chronic Dis. 2010 Jan;7(1):A19. Epub 2009 Dec 15.
- Post RM, Roy-Byrne PP, Uhde TW. Graphic representation of the life course of illness in patients with affective disorder. Am J Psychiatry. 1988 Jul;145(7):844-8. doi: 10.1176/ajp.145.7.844.
- Born C, Amann BL, Grunze H, Post RM, Scharer L. Saving time and money: a validation of the self ratings on the prospective NIMH Life-Chart Method (NIMH-LCM). BMC Psychiatry. 2014 May 7;14:130. doi: 10.1186/1471-244X-14-130.
- Denicoff KD, Ali SO, Sollinger AB, Smith-Jackson EE, Leverich GS, Post RM. Utility of the daily prospective National Institute of Mental Health Life-Chart Method (NIMH-LCM-p) ratings in clinical trials of bipolar disorder. Depress Anxiety. 2002;15(1):1-9. doi: 10.1002/da.1078.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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